Twelve‐Month Outcomes of Eustachian Tube Procedures For

Twelve-Month Outcomes of Eustachian Tube Procedures for Management of Patulous Eustachian Tube Dysfunction

Bryan K. Ward, MD; Wei-Chieh Chao, MD; Godwin Abiola, BA; Kosuke Kawai, ScD; Yehia Ashry, MD; Tali Rasooly, BA; Dennis S. Poe, MD, PhD

Objective: To determine the 12-month effectiveness of transnasal–transoral endoscopic surgical procedures for eliminat- ing symptoms of patulous Eustachian tube dysfunction (PETD). Study Design: Retrospective chart review Methods: Patients with medically refractory PETD underwent one of the following procedures: 1) shim (catheter) insertion, 2) calcium hydroxyapatite injection, 3) patulous Eustachian tube (ET) reconstruction, or 4) obliteration of the ET lumen. Time to recurrence of any PETD symptoms was recorded, and success was determined as complete symptom resolution at 12 months. The frailty model, an extension of the Cox proportional hazards model, was used for the survival analysis. Results: A total of 241 procedures were performed in 80 patients. Median duration of symptom relief after surgery was 5.0 months (interquartile range [IQR]: 1.1–15.5 months) and varied by procedure type, ranging from 3.0 months (IQR: 0.7–7.0 months) for calcium hydroxyapatite injection to 20.6 months (3.4–35.9 months) for obliteration. Compared to shim insertion, the risk of 12-month failure was significantly higher for calcium hydroxyapatite injection (hazard ratio [HR] = 2.18; 95% confidence interval [CI] 1.29, 3.67; P = 0.004) and patulous ET reconstruction (HR = 1.62; 95% CI 1.04, 2.52; P = 0.035). Patients undergoing shim insertion (52.2%) and obliteration (81.8%) were likely to require pressure equalization tubes or to have had otitis media with effusion. Conclusion: Although all procedures potentially resulted in symptom resolution, placement of a shim or obliteration of the ET lumen was more likely to achieve 12-month resolution of PETD symptoms and more likely to result in otitis media with effusion than hydroxyapatite injection or patulous ET reconstruction. Key Words: Patulous Eustachian tube, autophony, Eustachian tube. Level of Evidence: Level 4 Laryngoscope, 129:222–228, 2019

INTRODUCTION lateral cartilaginous lamina, Ostmann’s fat, and the ten- Patulous Eustachian tube dysfunction (PETD) is sor veli palatini muscle (TVP). Patients report the percep- thought to result from a longitudinal concave defect in tion of their own voices and nasal breathing sounds as the mucosal functional valve, usually in the anterolateral being abnormally loud (autophony) or distorted, and they wall of the Eustachian tube (ET). The anterolateral wall may additionally experience aural fullness or pulsatile of the functional valve normally has a convex bulge into tinnitus.1–7 Although these symptoms can be persistent, the lumen that is comprised of mucosa, submucosa, the they are often intermittent, triggered by activities such as exercise or prolonged talking,8 and relieved by an From the Department of Otolaryngology–Head and Neck Surgery, upper respiratory tract infection causing nasal congestion Johns Hopkins School of Medicine (B.K.W., G.A.), Baltimore, Maryland; or when in a recumbent position. Department of Otolaryngology and Communication Enhancement, Boston Children’s Hospital and Harvard Medical School (K.K., Y.A., T.R., D.S.P.), To diagnose PETD, clinicians should observe medial Boston, Massachusetts, U.S.A; Department of Otolaryngology, Chang and lateral excursions of the tympanic membrane coinci- Gung Memorial Hospital, Keelong, Chang Gung University (W-C.C.), Taoyuan, Taiwan dent with ipsilateral nasal breathing at a time when the Editor’s Note: This Manuscript was accepted for publication on patient’s autophony is active. This can be seen best with June 20, 2018. the patient seated upright because lying supine may Bryan K Ward, MD and Wei-Chieh Chao, MD contributed equally to this work. cause venous congestion around the ET, closing the valve. Presented at the Triological Society Combined Otolaryngology Movements of the tympanic membrane will not be Spring Meetings (COSM), National Harbor, Maryland, U.S.A., April 20, 2018. observed when the patient is asymptomatic. Dennis Poe is a paid consultant for Acclarent, Inc., but has no There is no standard treatment for PETD. Manage- equity interest; he completed a trial for Eustachian tube dilation balloons ment begins with discontinuing agents that can exacer- and has financial interest in nasal spray for otitis media (not yet in phase I trials). The authors have no other funding, financial relationships, or bate symptoms, such as caffeine, decongestants, topical conflicts of interest to disclose. nasal steroids, and diuretics if medically appropriate.8,9 Send correspondence to Bryan K. Ward, MD, Johns Hopkins Outpa- tient Center, 6th floor, Department of Otolaryngology–Head and Neck Increased hydration and nasal saline drops or irrigations Surgery, 601 North Caroline Street, Baltimore, MD 21287. can be helpful. Mucus-thickening agents, topical estrogen E-mail: [email protected] drops, and topical irritants can induce mucosal edema or DOI: 10.1002/lary.27443 thickening and are effective, but they usually provide

Laryngoscope 129: January 2019 Ward et al.: Patulous Eustachian Tube Dysfunction Outcomes 222 temporary relief. Although weight gain has been sug- the center of the lumen’s cross-sectional area may be selected for gested as a remedy, it is rarely effective and not recom- injection. PETR was usually performed for failure of the above mended unless the patient is medically underweight.7 two procedures, and obliteration was used for failure of PETR. Surgical management of PETD can include addres- Some patients underwent surgery on bilateral ETs, and some underwent multiple procedures if they had inadequate sing the middle ear by placing a tympanostomy tube, 10,11 symptom control from a prior patulous ET surgery. No patient mass loading of the tympanic membrane, or placing a underwent obliteration of the ET lumen as a first procedure. 12–16 transtympanic plug. Other approaches address the Techniques were classified as shim placement if a foreign nasopharyngeal end of the ET and include inserting an material was inserted into the ET lumen from the nasopharynx angiocatheter surrounded by bone wax for occlusion of and the material could later be removed, without permanently the ET lumen,8,9,17 augmentation with calcium hydroxy- altering the ET anatomy. An intravenous angiocatheter (14–18 apatite cement,18,19 surgically reconstructing the ET gauge) was filled with bone wax by aspirating molten wax into valve,8,20–24 or permanently obliterating the ET lumen.20 the lumen, allowing it to harden, then trimming the Luer lock Two recent systematic reviews showed a wide range of side to a length usually 38 to 40 mm for females and 40 to outcomes with heterogeneous study design, limiting the 42 mm for males. It was loaded into an insertion tool (Karl Storz, Culver City, CA), passed transorally up to the orifice of the ET, ability to compare groups.25,26 There is little data on and then inserted into the full length of the lumen. Mild resis- long-term outcomes of the above nasopharyngeal proce- tance was noted as it passed through the isthmus, which would dures, and there have been no studies at a single institu- hold the shim in position over time. The shim, being flexible, tion comparing outcomes among them. This study aims to would lay into the longitudinal concave defect in an attempt to examine the 12-month effectiveness of these procedures. restore competency for closure of the functional valve. A procedure was classified as calcium hydroxyapatite injection if a permanent filler material was injected deep to the mucosal surface of the cartilaginous portion of the ET in order to MATERIALS AND METHODS increase the bulk within the functional valve. Injection of calcium All outpatient clinic visits to the senior author (2004–2016, hydroxyapatite cement was performed by guiding a needle D.S.P.) were queried for the assigned International Classification transorally or transnasally and injecting submucosally around of Diseases, 9th revision diagnosis code 381.7 Patulous Eusta- the lumen of the ET and longitudinally along the length of the chian tube. Each patient’s medical record was then reviewed cartilaginous portion. The senior investigator (D.S.P.) used visual (n = 340). Those patients undergoing surgery for PETD (n = 96, feedback to determine the amount of calcium hydroxyapatite 28.2%) were retrospectively reviewed for demographics, risk fac- injected. Tympanostomy tubes were not routinely placed during tors, physical examination findings, and the duration of symptom procedures for shim placement or calcium hydroxyapatite resolution after surgery. The diagnosis of PETD was made based injection. on the presence of symptoms consistent with PETD (breath Procedures were classified as PETR if they involved tech- autophony, aural fullness, and voice distortion), the exclusion of niques to narrow the lumen of the ET in order to restore its com- disorders with overlapping symptoms, and evidence of synchro- petency as a valve and without intending to completely occlude nous movement of the tympanic membrane in response to ipsilat- the lumen. The reconstruction techniques varied over time, but eral nasal breathing on otoscopy or acoustic reflex decay mode all had the intended goal of narrowing the ET valve by extralum- testing. Prior to undergoing surgery, all patients underwent a inal compression. Techniques included transposition of the trial of medical management for at least 6 months, including medial cartilaginous lamina or establishing a submucosal pocket increased hydration, topical nasal therapies such as saline or with insertion of different materials such as fat, cartilage, acellu- ascorbic acid drops, and removing decongestants and caffeine. lar dermal matrix (Alloderm, LifeCell Corp., Branchburg, NJ), Four classes of transnasal–transoral endoscopic procedures and silicone to decrease the lumen diameter of the ET (tech- were performed to repair PETD. Surgical procedures included 1) niques previously reported8). Obliteration of the ET lumen is per- insertion of an intravenous catheter (shim) into the full length of formed as in PETR, except the mucosa is circumferentially the ET lumen (off-label use), 2) injection of calcium hydroxyapa- denuded with the intent of inducing atresia of the tite cement (ProLaryn Plus, BioForm Medical, San Mateo, CA; ET. Tympanostomy tube placement or myringotomy was rou- off-label use) into the submucosa of the ET to provide bulk, 3) tinely performed at the time of PETR or obliteration of the patulous ET reconstruction (PETR) by a variety of methods to ET. Figure 1 shows sample surgical images of the four procedure decrease the lumen diameter, or 4) permanent obliteration of the classes. ET lumen. All procedures were performed as outpatient surgery All patients undergoing surgery during the study period under general anesthesia, and transnasal endoscopic assistance were included in the analysis if they had follow-up of at least was used to view the lumen of the ET from its nasopharyngeal 12 months after surgery; each ET was counted as a separate pro- orifice. All of the procedures were performed with a 45-degree cedure. Patient demographics and clinical characteristics were nasal endoscope (Karl Storz, Culver City, CA) in the ipsilateral compared by procedure type using chi-square test for categorical nasal cavity for viewing, and instruments passed transorally. variables and Kruskal-Wallis and Wilcoxon rank sum tests for Selection of the procedure was determined based on the size and continuous variables. Kaplan-Meier survival curves were con- location of the concave defect within the valve or whether previ- structed for each procedure to compare the risk of failure during ous procedures had been performed. A minimally invasive proce- the first year, for which failure was defined as the patient- dure was generally selected as an initial procedure, either by reported recurrence of any symptoms of PETD in the affected ear. insertion of a shim or injection with calcium hydroxyapatite. The This was recorded by reviewing the records for any contact with most common defects were located in the valve at or adjacent to the patient about symptoms after surgery, and in some cases con- the 12:00 position within the lumen, where the mucosa is thin tacting the patient via telephone. The frailty model, which is an and tightly bound to the cartilage. Injection would be unfavor- extension of the Cox proportional hazards model that incorporates able in that location because the submucosa would not hold much cluster-specific random effects, was employed to account for the of the filler material. Therefore, insertion of a shim was most correlation between ears and correlation from repeated surgeries commonly used. Small defects that were favorably located near within an individual. The lognormal distribution was specified for

Laryngoscope 129: January 2019 Ward et al.: Patulous Eustachian Tube Dysfunction Outcomes 223 Fig. 1. Examples of each of class of surgical approaches used in this series to repair a patulous ET, all right side. The upper panel shows shim insertion into the lumen of an ET before, during, and after insertion. The second panel shows an injection of calcium hydroxyapatite submucosally to decrease the size of the ET lumen. The third shows a patulous ET reconstruction, in which the mucosa of an ET was denuded except for a strip along the inferior border, and the ET was sutured closed. The final series shows a total obliteration of the ET, in which mucosa was circumferentially denuded and the lumen was sutured closed, resulting in atresia of the ET. ET = Eustachian tube. the frailty term. Hazard ratio (HR) and 95% confidence interval outpatient surgeries (range 1–10). Demographics for (CI) were estimated. Model diagnostics were performed to evalu- included patients are shown in Table I. ate the fit of the model and confirm the proportional hazards Of the procedures included for analysis, the most assumption. All analyses were conducted using SAS version 9.4 common was shim insertion (n = 115, 47.8%), followed by (SAS Institute Inc., Cary, NC) and R statistical software. This ret- PETR (n = 77, 31.9%), calcium hydroxyapatite injection rospective study was approved by the Boston Children’s Hospital (n = 38, 15.7%), and ET obliteration (n = 11, 4.6%). Data internal review board, Boston, Massachusetts. for the included procedures is shown in Table II. For all procedures, the median duration of complete symptom relief was 5.0 months (interquartile range RESULTS [IQR]: 1.1–15.5 months) (Table III), and the risk of symp- During the study period, 276 ET procedures were tom reappearance within 12 months was 50.6% (122 of performed on 96 patients. We excluded 16 patients who 241 procedures). The median duration of symptom relief underwent 35 procedures due to the lack of evidence in varied by procedure class, which ranged from 3.0 months the records of definite pressure transmission to the mid- (IQR: 0.7–7.0 months) for calcium hydroxyapatite injec- dle ears (n = 11 patients) or due to the lack of 12-month tion to 20.6 months (3.4–35.9 months) for ET obliteration. follow-up (n = 5 patients, n = 6 procedures). One patient All 11 patients who underwent ET obliteration had reso- who underwent bilateral PETR was lost to follow-up, as lution of PETD symptoms at 12 months. The second low- well as one patient each who underwent unilateral oblit- est frequency of disease recurrence within 12 months eration, PETR, calcium hydroxyapatite injection, and occurred with shim insertion at 24.6%. Compared to shim shim insertion. We included 241 procedures (176 outpa- placement, risk of 12-month failure was significantly tient surgeries) performed on 80 patients. Patients under- higher for calcium hydroxyapatite injection (hazard ratio went a mean of 3.0 ET procedures (range 1–17) or 2.2 [HR] = 2.18; 95% confidence interval [CI] 1.29, 3.67;

Laryngoscope 129: January 2019 Ward et al.: Patulous Eustachian Tube Dysfunction Outcomes 224 TABLE I. failure (HR = 2.37; 95% CI 1.09, 5.16; P = 0.03). Among Demographics, All Patients (n = 80 patients) patients undergoing calcium hydroxyapatite injection, a greater amount of material injected was associated with Mean (SD) lower likelihood of symptom resolution (HR = 2.15; 95% Age, years 38.4 (17.6) CI 1.14, 4.07; P = 0.018) (Table IV). Surgical experience (range: 11 – 84) did not impact outcomes because there were no differ- Symptom 6.8 (8.3) ences in likelihood of symptom resolution at 12 months duration, years for any procedure in the first 6 years (2004–2010) com- n (%) pared to the second 6 years (2011–2016; P > 0.05). Gender Male 37 (46%) Female 43 (54%) Affected side Right 22 (28%) Complications Left 12 (15%) The procedures were well tolerated with a surgical Bilateral 46 (58%) complication rate of 3.4% (n = 6 out of 176 outpatient sur- Symptoms Voice distortion 78 (98%) geries). Uvula edema occurred in three patients undergoing PETR and one undergoing bilateral shim placement. Breath autophony 76 (95%) Tongue edema with temporary change in taste occurred Aural fullness 46 (58%) in one patient undergoing PETR. One patient developed Pulsatile tinnitus 21 (27%) an infratemporal fossa hematoma resulting in lingual Crackling/rumbling sound 16 (20%) nerve hypesthesia (ipsilateral numbness of tongue, gin- Comorbidities Environmental allergies 30 (38%) giva, and lower lip; altered taste) after calcium hydroxy- Weight loss at symptom onset 29 (36%) apatite injection that improved over months. There were Gastroesophageal reflux disease 27 (34%) no carotid artery injuries. Reported stress and anxiety 22 (28%) At surgery, 17% (n = 20) of ears undergoing a shim Oral contraceptive use 12 (15%) insertion, 21% (n = 8) undergoing hydroxyapatite injec- Rheumatologic conditions 13 (16%) tion, 78% undergoing PETR (n = 60), and 100% (n = 11) Temporomandibular disorder 8 (10%) undergoing obliteration had a tympanostomy tube in place or received a new one. Patients undergoing shim Currently smoking 7 (9%) Hormone replacement therapy use 3 (4%) Pregnant at start of symptoms 3 (4%) TABLE II. Included Procedures (n = 241 procedures) Neuromuscular disease 2 (3%) None 11 (14%) Shim insertion 115 (48%) Prior treatments Shim length (mm), mean (SD) 38 (2.1) Medical therapy Ascorbic acid (PatulEnd) 40 (50%) (range: 30–42) Conjugated estrogens (Premarin) 37 (46%) Shim width (gauge), mean (SD) 14.5 (1.0) (range: 14–18) Saturated solution of 19 (24%) potassium iodide Hydroxyapatite injection, n (%) 38 (16%) Hypertonic saline 16 (20%) Amount injected (mL), mean (SD) 1.2 (0.6) (range: 0.2–2.5) Procedural therapy Tympanostomy tube 26 (33%) Patulous Eustachian tube 77 (32%) Injection of filler 12 (15%) reconstruction Patulous Eustachian 8 (10%) Submucosal pocket, n (%) 36 (46%) tube reconstruction Cartilage transposition, n (%) 18 (23%) Shim insertion 3 (4%) Simultaneous hydroxyapatite 10 (13%) Botox injection 1 (1%) injection, n (%) PatulEnd (The Ear Foundation, Santa Clara, CA), Premarin (Pfizer, New Reconstruction material York, NY). Alloderm, n (%) 22 (25%) SD = standard deviation. Cartilage, n (%) 28 (36%) P = 0.004) and PETR (HR = 1.62; 95% CI 1.04, 2.52; Fat, n (%) 24 (31%) P = 0.035) (Table IV) (Fig. 2). Patients undergoing a pro- Fascia, n (%) 2 (3%) cedure for the first time (n = 109) had a higher risk of Silicone, n (%) 2 (3%) failure in the first 12 months after calcium hydroxyapa- None, n (%) 2 (3%) tite injection (HR = 4.92; 95% CI 2.30, 10.51; P < 0.001) Obliteration 11 (5%) and PETR (HR = 2.09; 95% CI 1.00, 4.34; P = 0.04) than Obliteration material after shim insertion (Figure 3). For patients who were Alloderm, n (%) 4 (36%) excluded but for whom we had adequate follow-up data, the rates of symptom resolution at 12 months were simi- Fat, n (%) 4 (36%) lar to that of all included procedures. Fascia, n (%) 3 (27%)

Among patients undergoing PETR, the use of fat as Alloderm, LifeCell Corp, Branchburg, NJ. a filler material was associated with a higher rate of SD = standard deviation.

Laryngoscope 129: January 2019 Ward et al.: Patulous Eustachian Tube Dysfunction Outcomes 225 TABLE III. Surgical Treatment of Patulous Eustachian Tube (241 procedures from 80 patients)

By Procedure Class Overall (n = 241) Shim (n = 115) HA Injection (n = 38) PETR (n = 77) Obliteration (n = 11) P Value

Duration of symptom relief, months 0.011 Mean (SD) 13.2 ( ± 21.1) 14.4 ( ± 21.2) 7.7 ( ± 14.6) 12.1 ( ± 21.2) 28.0 ( ± 32.1) Median (IQR) 5.0 (1.1–15.5) 6.0 (1.9–18.0) 3.0 (0.7–7.0) 4.6 (0.7–15.0) 20.6 (3.4–35.9) Symptom recurrence within 1 year 122 (50.6%) 45 (39.1%) 26 (68.4%) 51 (66.2%) 0 (0%) < 0.001 Required PET/OME 81 (33.6%) 60 (52.2%) 4 (10.5%) 8 (10.4%) 9 (81.8%) < 0.001

HA = hydroxyapatite; IQR = interquartile range; OME = otitis media with effusion; PET = pressure equalization tube; PETR = patulous Eustachian tube reconstruction; SD = standard deviation. insertion (52.2%) or obliteration (81.8%) were more likely undergoing shim placement (n = 115), 14 (12%) shims to require subsequent tympanostomy tubes or to develop became dislodged: six had partial displacement presenting otitis media with effusion than those who received either as pain (n = 2) or return of symptoms (n = 4); and hydroxyapatite injection (10.5%) or PETR (10.4%). Of those eight had complete displacement, being expelled either via spitting up (n = 2), sneezing, or blowing out the nose (n = 4). In two cases, the patient was assumed to have TABLE IV. swallowed the catheter because they developed symptoms Risk of Symptom Reappearance Within 1 Year After Surgical but were unaware that the catheter was missing. There Treatment of Patulous Eustachian Tube Dysfunction were no instances of aspiration of a shim. In four cases, % HR (95% CI) P Value bone wax from the shim partially extruded into the middle ear and was removed via myringotomy. Based on first procedure (n = 109) Shim insertion 24.6% Reference Hydroxyapatite injection 63.2% 4.92 (2.30, 10.53) < 0.001 DISCUSSION Patulous ET reconstruction 52.0% 2.09 (1.00, 4.34) 0.04 Half of patients experienced resolution of their PETD symptoms lasting over 1 year, similar to rates of symptom All procedures (n = 241) resolution reported in two recent meta-analysis.25,26 There Shim insertion 39.1% Reference were differences, however, among the procedures in the Hydroxyapatite injection 68.4% 2.18 (1.29, 3.67) 0.004 duration of symptom resolution. Placement of a shim had Patulous ET reconstruction 66.2% 1.62 (1.04, 2.52) 0.035 lower rates of failure at 12 months compared to injection Obliteration 0% – of calcium hydroxyapatite cement and to procedures Prior PETR procedure intending to reconstruct the ET lumen. Approximately Yes 62.5% 1.45 (0.98, 2.14) 0.05 three-quarters of patients undergoing a shim placement as No 42.8% Reference their first procedure on the ET experienced resolution of Details of each procedure Shim placement Length (range: 30–42 mm) – 0.98 (0.83, 1.16) 0.81 Width (range: 14–18 gauge) – 0.90 (0.65, 1.26) 0.54 Hydroxyapatite injection Volume injected – 2.15 (1.14, 4.07) 0.018 (range: 0.2–2.5 mL) Patulous Eustachian tube reconstruction Presence of cartilage 55.6% 0.94 (0.47, 1.89) 0.87 transposition Submucosal pocket 61.1% 0.74 (0.42, 1.29) 0.29 Accompanying hydroxyapatite 80.0% 1.32 (0.62, 2.83) 0.47 injection Type of materials Alloderm 55.6% Reference Cartilage 60.7% 1.17 (0.54, 2.56) 0.70 Fat 81.8% 2.37 (1.09, 5.16) 0.03 Others 66.7% 1.64 (0.59, 4.53) 0.34 Fig. 2. Surgical management of patulous Eustachian tube for all procedure classes (241 procedures; log-rank test P < 0.001). HR = Alloderm, LifeCell Corp, Branchburg, NJ. hazard ratio; PETR = patulous Eustachian tube reconstruction. CI = confidence interval; ET = Eustachian tube; HR, hazard ratio; [Color figure can be viewed in the online issue, which is available at PETR = patulous Eustachian tube reconstruction. www.laryngoscope.com.]

Laryngoscope 129: January 2019 Ward et al.: Patulous Eustachian Tube Dysfunction Outcomes 226 placement were likely to require subsequent tympanostomy tube placement, suggesting a relationship between the effectiveness of the procedure for reducing PETD symptoms and the likelihood of interfering with the normal dilatory function of the ET. Total obliteration of the ET lumen successfully resolves PETD symptoms; however, this results in chronic middle ear effusions that also produce symptoms of aural fullness and autophony. The chronic effusions are often thick and mucoid and frequently occlude tympanostomy tubes.29 Although anecdotally patients are con- tent to be relieved of their PETD, these chronic mucoid effusions are difficult to manage. Total ET obliteration should be carefully considered only as a last resort. The injection of hydroxyapatite cement and PETR tended to perform worse than shim placement or total Fig. 3. Surgical management of patulous ET for first procedure per- obliteration. Injecting a larger volume of filler was also formed on the ET. ET = Eustachian tube; HR = hazard ratio; associated with a lower likelihood of enduring symptom PETR = patulous Eustachian tube reconstruction. [Color figure can be viewed in the online issue, which is available at www. relief. This may be the result of calcium hydroxyapatite laryngoscope.com.] being less successful in larger defects, with the injected filler tending to diffuse away from the lumen. Although there is currently no measure of the size of the defect, symptoms 12 months later. Although the shim can remain variations in the size of the defect in the anterolateral in place for years, it became dislodged in 12% of patients. wall has been observed by the senior author (D.S.P). In the majority of these cases, this was expelled via a Among the four classes of transnasal, transoral cough or sneeze. There were no cases of aspiration. Roten- endoscopic ET procedures in this study, PETR had the berg et al. has reported success in suturing the shim to greatest variability in technique. The procedures had a nasopharyngeal mucosa in a smaller series.17 Others have common goal of restoring the normal convexity of the reported similar success using a transtympanic approach anterolateral wall of the ET; nevertheless, the group was to the bony ET via an anterior tympanotomy or myringot- heterogeneous. We attempted to account for this by omy to either occlude its lumen with an angiocatheter13,16 adjusting for different techniques as variables in our or to place a shim.12,15 In general, the surgeries were well analysis. The use of Alloderm (LifeCell Corp.) was associ- tolerated, with no carotid artery injuries and a low rate of ated with a lower chance of failure, and the use of autolo- perioperative complications, mostly related to palate gous fat was associated with a higher chance of failure. retraction during longer procedures such as PETR. This may be due to qualities of the material and the like- Although placement of a tympanostomy tube has lihood of its becoming dislodged or absorbed. In several been reported to reduce symptoms in up to 54% of cases in which autologous fat was used as the filler in the patients with PETD,10 it may also exacerbate them.27 In reconstruction, patients reported the fat becoming dis- patients in whom tympanostomy tubes are effective, they lodged. Ongoing work is being done to improve the tech- may work by mass loading the tympanic membrane or by niques for PETR in the goal of yielding better long-term providing a route for pressure equalization, thereby mini- results. mizing excursions of the tympanic membrane.28 In this Although this study compares outcomes among series, 33% of patients underwent tympanostomy tube transnasopharyngeal approaches for PETD, it is not placement prior to pursuing additional treatment, and exhaustive. Other nasopharyngeal techniques include 20% (n = 5) reported that the tube made their symptoms procedures affecting the TVP muscle or tendon.30,31 worse. Some patients undergoing ET surgery also had a Whereas in this study calcium hydroxyapatite was used tympanostomy tube placed during the procedure in order as a semipermanent filler, others have used materials to address temporary ET dilatory dysfunction caused by such as fat or cartilage,20,24 absorbable gelatin,32 polydi- the procedure. Concomitant placement of tympanostomy methylsiloxane elastomer,27,33 and Teflon paste.34 Polydi- tube was uncommon among those undergoing shim inser- methylsiloxane elastomer (Vox, Endotherapeutics, tion or calcium hydroxyapatite injection but common Epping NSW, Austrailia) is currently unavailable in the among those undergoing PETR and obliteration. For United States, and Teflon has been abandoned due to PETR, it was thought that these procedures might more instances of cerebral embolism and death, possibly from likely result in temporary effusion because the lumen was injection of Teflon into the internal carotid artery. functionally occluded by the combination of surgical Improved endoscope technology, knowledge of the loca- reduction of the lumen and intraoperative swelling of the tion of the defect in the valve within the lumen of the ET, tissues. Despite having the lowest rate of simultaneous and attention to the surgical anatomy of the relationship tympanostomy tube placement, insertion of a shim had between the ET and the internal carotid artery have the highest rate of symptom resolution, indicating the likely improved the accuracy and safety of injections. tympanostomy tube did not meaningfully confound the Finally, techniques have also been developed to mass load results. Nevertheless, patients undergoing shim the tympanic membrane, with the majority of patients

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